NCT07407075

Brief Summary

This study is a cross-sectional and comparative clinical investigation designed to examine the relationship between periarticular muscle strength imbalance and kinesiophobia levels in individuals with meniscal injuries receiving postoperative or conservative treatment, and to determine whether this relationship differs according to the treatment modality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
Last Updated

March 16, 2026

Status Verified

February 1, 2026

Enrollment Period

24 days

First QC Date

February 6, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

Meniscus InjuriesKinesiophobiaBlazePodPain

Outcome Measures

Primary Outcomes (2)

  • Muscle Strength

    Muscle strength will be assessed using a standardized isometric dynamometer. It will be applied to the quadriceps and hamstring muscles.This will be used to objectively measure isometric muscle strength and determine the difference/asymmetry of strength between the affected and unaffected extremities. This measure quantitatively reflects lower extremity muscle performance and potential functional strength loss.

    Baseline. The assessment will be conducted once during the study period.

  • Tampa Kinesiophobia Scale (TKS-17)

    This is a self-report scale that assesses avoidance of movement and fear of re-injury. It consists of 17 articles. The scale will be completed using a 4-point Likert scale (1=Strongly disagree, 4=Strongly agree), and the total score will range from 17 to 68.

    Baseline. The evaluation is conducted only once during the research process.

Secondary Outcomes (6)

  • Visual Analog Scale (VAS)

    Baseline. The evaluation will be conducted once during the study period.

  • Single Leg Hop Test

    Baseline. The evaluation will be conducted once during the study period.

  • International Knee Documentation Committee (IKDC)

    Baseline, The evaluation will be conducted once during the study period.

  • Lysholm Knee Scale

    Baseline. The evaluation will be conducted once during the study period.

  • Reaction Time Assessment (BlazePod)

    Baseline. The evaluation will be conducted once during the study period.

  • +1 more secondary outcomes

Study Arms (2)

Post-operative Meniscus Group

This group will consist of individuals who have undergone surgical intervention (meniscectomy or meniscal repair) due to medial meniscal injury confirmed by magnetic resonance imaging (MRI). Participants will be required to have completed at least a three-week postoperative recovery period and to be actively continuing a routine rehabilitation program.

Conservative Treatment Group

This group will consist of individuals with MRI-confirmed medial meniscal injury who are managed conservatively without surgical intervention and are followed through non-operative approaches such as physiotherapy, exercise, and medical treatment. Participants will be required to have at least two months elapsed since the injury and to be actively engaged in an ongoing rehabilitation program.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consists of a total of 50 male and female individuals aged between 18 and 50 years who have been diagnosed with medial meniscal injury and are undergoing either postoperative or conservative treatment.

You may qualify if:

  • Being between 18 and 50 years of age, with a diagnosis of meniscal injury (male or female)
  • Having a medial meniscal injury confirmed by magnetic resonance imaging (MRI)
  • Presence of a unilateral injury
  • Voluntary agreement to participate in the study
  • A minimum of 3 weeks having elapsed since surgery for postoperative participants
  • A minimum of 2 months having elapsed since injury for participants receiving conservative treatment

You may not qualify if:

  • Concomitant anterior cruciate ligament (ACL) injury or additional ligament injuries such as posterior cruciate ligament (PCL), lateral collateral ligament (LCL), or medial collateral ligament (MCL)
  • History of fracture or significant trauma to the lower extremity within the past 6 months
  • Current or previous neurological disorders (e.g., stroke, multiple sclerosis, peripheral neuropathy, Parkinson's disease)
  • Vestibular system disorders or any conditions affecting balance
  • Presence of a second surgical intervention or postoperative complications
  • Osteoarthritis with a Kellgren-Lawrence grade ≥ 2
  • Contracture or severe limitation of knee range of motion restricting joint mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medipol Bahçelievler Üniversite Hastanesi

Istanbul, Bahçelievler, 34196, Turkey (Türkiye)

Location

Biruni University

Istanbul, Zeytinburnu, 34025, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaPain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Begüm KARA KAYA, PhD

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Physiotherapist

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

February 6, 2026

Primary Completion

March 2, 2026

Study Completion

March 9, 2026

Last Updated

March 16, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers due to ethical and confidentiality considerations.

Locations